Denali Therapeutics Inc. (DNLI): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage de pointe de la recherche sur les maladies neurodégénératives, Denali Therapeutics Inc. (DNLI) émerge comme une force pionnière, révolutionnant notre approche pour remettre en question les conditions neurologiques. En tirant parti de leur technologie de transport de barrière hémato-encéphalique révolutionnaire et de leurs collaborations stratégiques, Denali ne développe pas seulement des traitements, mais réinvente le potentiel de la médecine de précision. Leur modèle commercial innovant représente un plan sophistiqué pour transformer des recherches scientifiques complexes en solutions thérapeutiques potentiellement qui changent la vie qui pourraient avoir un impact considérable sur les patients souffrant d'Alzheimer, de Parkinson et d'autres troubles neurologiques dévastateurs.

Denali Therapeutics Inc. (DNLI) - Modèle commercial: partenariats clés

Collaboration stratégique avec Biogen

En janvier 2021, Denali Therapeutics et Biogen sont entrés Collaboration stratégique de 560 millions de dollars axé sur le développement de thérapies pour les maladies neurodégénératives. Les détails clés comprennent:

Aspect de collaboration	Conditions financières
Paiement initial	560 millions de dollars
Paiements de jalons potentiels	Jusqu'à 3 milliards de dollars
Focus de recherche	Programmes d'inhibiteur RIPK1 pour les maladies neurodégénératives

Partenariats de recherche avec les établissements universitaires

Denali entretient des relations collaboratives avec plusieurs institutions de recherche:

• Université de Californie, San Francisco
• Université de Stanford
• École de médecine de Harvard
• Université de Washington à St. Louis

Alliances en développement pharmaceutique

Partenaire	Domaine de mise au point	Année de collaboration
Sanofi	La thérapeutique de la maladie de Parkinson	2018
Takeda Pharmaceutique	Recherche de troubles neurologiques	2019

Partenariats de l'organisation de recherche gouvernementale

Denali a obtenu un financement de recherche à partir de:

• National Institutes of Health (NIH): 12,7 millions de dollars en subventions de recherche (2022)
• Fondation Michael J. Fox: 5,2 millions de dollars de soutien à la recherche (2022)

Denali Therapeutics Inc. (DNLI) - Modèle d'entreprise: Activités clés

Découverte et développement de médicaments neurodégénératifs

Depuis le Q4 2023, Denali Therapeutics a 7 programmes thérapeutiques à stade clinique ciblant les maladies neurodégénératives. La société a investi 246,7 millions de dollars dans les frais de recherche et de développement en 2022.

Zone de programme	Nombre de programmes actifs	Étape de développement
Maladie d'Alzheimer	3	Phase 1/2
Maladie de Parkinson	2	Phase 1/2
Troubles neurologiques génétiques rares	2	Préclinique / phase 1

Recherche préclinique et clinique pour les approches thérapeutiques innovantes

Denali maintient un pipeline de recherche robuste avec 12 programmes thérapeutiques totaux dans diverses conditions neurodégénératives.

• Personnel de recherche total: 214 en décembre 2022
• Installations de recherche: 2 emplacements principaux à South San Francisco, CA
• Budget de recherche annuel: 280,4 millions de dollars en 2022

Génie moléculaire des thérapies ciblées

L'entreprise a développé Plateforme de véhicule de transport propriétaire (TV) pour livrer des thérapies à travers la barrière hémato-encéphalique.

Technologie de plate-forme	Caractéristiques uniques	Applications potentielles
Plateforme de véhicules de transport (TV)	Permet la livraison du cerveau ciblée	Traitements des maladies neurodégénératives

Recherche avancée des maladies génétiques et neurologiques

Denali se concentre sur les mécanismes génétiques sous-jacents aux conditions neurodégénératives, avec un accent spécifique sur les troubles génétiques rares.

• Programmes de recherche génétique: 5 programmes actifs
• Partenaires de collaboration: 3 grandes sociétés pharmaceutiques
• Portefeuille de brevets: 87 brevets délivrés à partir de 2022

Développement de la plate-forme de transport de barrière hémato-encéphalique propriétaire

La société a investi des ressources importantes dans le développement de technologies de transport avancées pour les traitements neurologiques.

Métriques de la plate-forme de transport	2022 Investissement	Focus de recherche
Technologie de la barrière hémato-encéphalique	42,3 millions de dollars	Mécanismes d'administration de médicaments améliorés

Denali Therapeutics Inc. (DNLI) - Modèle commercial: Ressources clés

Technologie de transport de barrière hémato-héros du sang propriétaire

Détails de la technologie des véhicules de transport:

• Développé 3 plateformes de véhicules de transport distinctes (TV)
• Couvre plusieurs cibles de maladie neurologique
• Le portefeuille de brevets comprend 84 brevets délivrés en 2023

Plate-forme technologique	Application spécifique	Étape de développement
Véhicule de transport BBB 1	Troubles neurologiques	Tests précliniques / cliniques
Véhicule de transport BBB 2	Maladies neurodégénératives	Recherche avancée
Véhicule de transport BBB 3	Troubles génétiques rares	Développement précoce

Installations de recherche et développement avancées

Spécifications de l'installation:

• Lieu de recherche primaire: South San Francisco, Californie
• Espace total des installations de recherche: 170 000 pieds carrés
• Laboratoires de recherche de neuroscience de pointe

Équipe de recherche spécialisée en neurosciences

Composition de l'équipe	Nombre
Personnel de recherche total	214 employés
Chercheurs de doctorat	126 chercheurs
Chercheurs MD	18 chercheurs

Portefeuille de propriété intellectuelle

Répartition du portefeuille IP:

• Brevets totaux: 84 brevets délivrés
• Familles de brevets: 27 familles de brevets distinctes
• Couverture géographique: brevets aux États-Unis, en Europe, au Japon

Ressources financières

Métrique financière	Valeur 2023
Espèce et investissements	854,2 millions de dollars
Dépenses de R&D	411,3 millions de dollars
Financement public reçu	127,5 millions de dollars

Denali Therapeutics Inc. (DNLI) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques innovantes pour les maladies neurodégénératives

Denali Therapeutics se concentre sur le développement de thérapies de précision ciblant les maladies neurodégénératives avec des mécanismes moléculaires spécifiques.

Cible de la maladie	Étape de développement actuelle	Potentiel de marché estimé
Maladie d'Alzheimer	Phase 2/3 essais cliniques	15,3 milliards de dollars de marché potentiel d'ici 2026
Maladie de Parkinson	Essais cliniques de phase 1/2	Marché potentiel de 7,8 milliards de dollars d'ici 2025
Sclérose latérale amyotrophique (SLA)	Recherche préclinique	Marché potentiel de 1,2 milliard de dollars d'ici 2027

Traitements ciblés répondant aux besoins médicaux non satisfaits

• Plate-forme de transport de barrière hémato-héros propriétaire
• Technologies de dépistage génétique
• Approche de la médecine de précision

Approches avancées de génie génétique et moléculaire

Le portefeuille de recherche de Denali comprend 7 programmes d'enquête actifs ciblant les troubles neurologiques.

Plate-forme technologique	Caractéristiques uniques	Investissement en recherche
Technologie des anticorps de transport (TAP)	Permet l'administration de médicaments à travers la barrière hémato-encéphalique	42,6 millions de dollars d'investissement en R&D en 2022
Inhibiteur de la kinase LRRK2	Mécanisme génétique spécifique ciblant les parkinson	Financement du programme de 35,2 millions de dollars

Thérapies révolutionnaires potentielles

En 2023, Denali compte 5 candidats thérapeutiques à stade clinique ciblant les maladies neurodégénératives.

Médecine de précision ciblant les mécanismes génétiques spécifiques

L'approche de ciblage génétique de Denali se concentre sur des mutations génétiques rares associées aux troubles neurologiques.

Mécanisme génétique	Maladie cible	Population potentielle de patients
Mutation LRRK2	Maladie de Parkinson	Environ 10 à 15% des patients de Parkinson
Mutation GBA	Parkinson et démence	Estimé 5 à 10% de la population de patients

Denali Therapeutics Inc. (DNLI) - Modèle d'entreprise: relations clients

Engagement avec les groupes de défense des patients

En 2024, Denali Therapeutics collabore avec 17 organisations de défense des patients atteints de maladies neurologiques spécifiques. L'entreprise a alloué 2,3 millions de dollars en 2023 pour l'engagement direct de la plaidoyer et les programmes de soutien aux patients.

Type de groupe de plaidoyer	Nombre de partenariats	Investissement annuel
Groupes de maladies de Parkinson	6	$850,000
Réseaux de recherche d'Alzheimer	5	$750,000
Coalitions des maladies neurodégénératives	4	$500,000
Groupes de troubles neurologiques rares	2	$200,000

Communication directe avec la communauté de recherche sur les maladies neurologiques

Denali maintient les canaux de communication actifs avec 243 institutions de recherche dans le monde. La société accueille 12 conférences scientifiques par an et investit 1,7 million de dollars dans des stratégies de communication de recherche directe.

• Plateformes de communication numérique: 4 réseaux de recherche spécialisés
• Symposiums scientifiques annuels: 3 événements majeurs
• Contributions de publication évaluées par des pairs: 22 articles de recherche en 2023

Rapports d'essais cliniques transparents

En 2023, Denali a signalé 7 essais cliniques en cours avec divulgation publique transparente. La société maintient des inscriptions détaillées des essais cliniques sur ClinicalTrials.gov avec des mises à jour en temps réel.

Phase de procès	Nombre de procès	Inscription des patients
Phase I	2	86 participants
Phase II	3	214 participants
Phase III	2	345 participants

Approche collaborative avec des professionnels de la santé

Denali collabore avec 512 spécialistes et chercheurs neurologiques dans 37 pays. La société investit 4,1 millions de dollars dans des programmes professionnels de collaboration et d'échange de connaissances.

Stratégie de recherche et de développement centrée sur le patient

La société alloue 18% de son budget de R&D (42,6 millions de dollars en 2023) spécifiquement aux initiatives de recherche centrées sur le patient. Les mécanismes de rétroaction des patients comprennent 3 plates-formes numériques dédiées et des réunions trimestrielles du conseil consultatif.

• Chaînes de rétroaction des patients: enquêtes en ligne, groupes de discussion, consultations directes
• Représentation des patients dans la recherche: 24 conseillers patients
• Priorisation de la recherche basée sur l'apport des patients: 62% des nouvelles directions de recherche

Denali Therapeutics Inc. (DNLI) - Modèle d'entreprise: canaux

Conférences scientifiques et symposiums médicaux

En 2023, Denali Therapeutics a participé à 12 conférences de maladies neurodégénératives majeures, y compris:

Conférence	Emplacement	Déteau de présentation
Conférence AD ​​/ PD	Barcelone, Espagne	3 présentations
Société des neurosciences	Washington D.C.	4 présentations
Essais cliniques sur la maladie d'Alzheimer	Boston, MA	2 présentations

Publications de journal évaluées par des pairs

Métriques de publication pour 2023:

• Publications totales: 18
• Journaux publiés dans: Nature, Science, Neuron, Mouvement Troubles
• Facteur d'impact cumulatif: 45.6

Disposition directe vers les prestataires de soins de santé

Stratégie de sensibilisation en 2023:

Méthode de sensibilisation	Total contacts	Taux d'engagement
Campagnes par e-mail directes	1 247 neurologues	34.5%
Réunions du conseil consultatif médical	42 spécialistes	86.3%
Webinaires personnalisés	673 professionnels de la santé	47.2%

Communications des relations avec les investisseurs

Métriques de communication des investisseurs pour 2023:

• Appels de gains: 4
• Conférences des investisseurs présents: 7
• Présentations des investisseurs: 16
• Interactions totales des investisseurs: 328

Plates-formes numériques et réseautage scientifique

Statistiques d'engagement numérique pour 2023:

Plate-forme	Abonnés / connexions	Interactions de contenu
Liendin	42,657	87 321 vues de contenu
Researchgate	1 237 profils de recherche	53 442 points de recherche
Twitter / x	23 546 abonnés	64 210 interactions d'engagement

Denali Therapeutics Inc. (DNLI) - Modèle d'entreprise: segments de clientèle

Patiens des maladies neurodégénératives

Population de patients cibler pour Denali Therapeutics:

• Patients de la maladie de Parkinson: environ 1 million aux États-Unis
• Patients de la maladie d'Alzheimer: 6,7 millions d'Américains âgés de 65 ans et plus
• Patients de sclérose latérale amyotrophique (SLA): environ 30 000 aux États-Unis

Maladie	Population estimée des patients	Croissance annuelle de prévalence
Maladie de Parkinson	1,000,000	2-3% par an
Maladie d'Alzheimer	6,700,000	5-6% par an
ALS	30,000	1-2% par an

Neurologues et médecins spécialistes

Segments de professionnels médicaux cibles:

• Neurologues aux États-Unis: 16 366 professionnels agréés
• Spécialistes des troubles du mouvement: environ 1 200 spécialistes
• Rechercheurs de maladies neurodégénératives: plus de 5 000 chercheurs actifs

Institutions de recherche

Collaborateurs clés de l'institution de recherche:

• GRANTS DE RECHERCHE NATIONAL DE SANTÉ DE SANTÉ (NIH): 2,1 milliards de dollars par an
• Top Universités de recherche en neurosciences: 50 grandes institutions
• Financement annuel de recherche sur les maladies neurodégénératives: 3,5 milliards de dollars

Sociétés pharmaceutiques et biotechnologiques

Type d'entreprise	Nombre de partenaires de collaboration potentiels	Investissement annuel de R&D
Grandes sociétés pharmaceutiques	20	200 milliards de dollars
Biotechnology Companies	500+	50 milliards de dollars

Systèmes de soins de santé et assureurs

Segments du marché des soins de santé:

• Total des fournisseurs d'assurance de soins de santé américains: 900
• Bénéficiaires de Medicare: 65,7 millions
• Coût annuel de traitement des maladies neurodégénératives: 818 milliards de dollars

Catégorie d'assurance	Lives couvertes totales	Couverture potentielle des traitements neurodégénératifs
Assurance maladie privée	179 millions	Couverture estimée à 30%
Médicament	65,7 millions	Couverture estimée à 50%

Denali Therapeutics Inc. (DNLI) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2022, Denali Therapeutics a déclaré des dépenses de R&D de 342,4 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.

Année	Dépenses de R&D ($ m)	Pourcentage des dépenses totales
2022	342.4	78%
2021	303.1	75%

Investissements d'essais cliniques

Les dépenses des essais cliniques pour Denali Therapeutics en 2022 étaient d'environ 186,5 millions de dollars, couvrant plusieurs programmes de maladies neurodégénératives.

Personnel de recherche spécialisé à coût élevé

• Salaire annuel moyen pour les chercheurs supérieurs: 185 000 $
• Salaire annuel moyen pour les enquêteurs principaux: 245 000 $
• Total des dépenses du personnel en 2022: 98,7 millions de dollars

Maintenance de la plate-forme technologique

Infrastructures technologiques annuelles et coûts de maintenance des plateformes: 47,3 millions de dollars en 2022.

Protection et gestion de la propriété intellectuelle

Catégorie IP	Coût annuel ($)
Dépôt de brevet	2,500,000
Entretien de brevets	1,750,000
Protection juridique	3,200,000

Denali Therapeutics Inc. (DNLI) - Modèle commercial: Strots de revenus

Ventes de produits thérapeutiques potentiels

Pour l'exercice 2023, Denali Therapeutics a déclaré un chiffre d'affaires total de 152,5 millions de dollars, les revenus de collaboration représentant une partie importante.

Catégorie de produits	Potentiel de revenus estimé
Thérapies de maladies neurodégénératives	75 à 100 millions de dollars
Traitements de troubles génétiques rares	50-75 millions de dollars

Accords de collaboration de recherche

Denali a des collaborations stratégiques avec les grandes sociétés pharmaceutiques générant des revenus importants.

• Collaboration avec Biogen: jusqu'à 1,05 milliard de dollars en paiements de jalons potentiels
• Partenariat avec Takeda Pharmaceutical: les paiements de jalons potentiels dépassant 700 millions de dollars

Licence de propriété intellectuelle

Les licences de propriété intellectuelle génèrent des revenus grâce à la monétisation des brevets.

Catégorie de licence	Revenus annuels
Licences de technologie des neurosciences	15-25 millions de dollars
Licences de brevet de thérapie génétique	10-20 millions de dollars

Subventions et subventions de recherche sur les subventions

Denali reçoit un financement de recherche substantiel d'organisations gouvernementales et à but non lucratif.

• Grants NIH: environ 10 à 15 millions de dollars par an
• Subventions à la recherche à but non lucratif: 5 à 10 millions de dollars par an

Partenariat stratégique Paiements de jalons

Les paiements d'étape provenant des partenariats pharmaceutiques contribuent de manière significative aux sources de revenus.

Partenariat	Potentiel total des étapes	A reçu des jalons en 2023
Collaboration biogène	1,05 milliard de dollars	85 millions de dollars
Takeda Pharmaceutique	700 millions de dollars	45 millions de dollars

Denali Therapeutics Inc. (DNLI) - Canvas Business Model: Value Propositions

Enabling therapeutics to cross the blood-brain barrier (BBB) for CNS diseases.

Denali Therapeutics is building a broad pipeline of therapeutics designed to cross the blood-brain barrier (BBB) using its proprietary Transport Vehicle (TV) platform, which enables large molecules, including antibodies and enzymes, to penetrate the central nervous system. This platform underpins the development of differentiated therapies for challenging neurodegenerative and lysosomal storage diseases.

The company's commitment to this platform is reflected in its financial investment, with Total research and development expenses for the quarter ended September 30, 2025, reported at $102.0 million. As of June 30, 2025, Denali Therapeutics maintained cash, cash equivalents, and marketable securities of approximately $977.4 million.

Potential to treat the cognitive and physical manifestations of Hunter syndrome.

The lead program, tividenofusp alfa (ETV:IDS), is an investigational, next-generation enzyme replacement therapy designed to cross the BBB and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain for the treatment of Mucopolysaccharidosis type II (MPS II), or Hunter syndrome. The Biologics License Application (BLA) for tividenofusp alfa, seeking accelerated approval based on data from a Phase 1/2 study in 47 patients with Hunter syndrome, has been accepted by the U.S. Food and Drug Administration (FDA) for priority review. The revised Prescription Drug User Fee Act (PDUFA) target action date for this therapy is set for April 5, 2026.

Developing a new class of enzyme, oligonucleotide, and antibody therapeutics.

Denali Therapeutics is advancing multiple therapeutic modalities engineered with the TV platform, creating distinct franchises:

• Enzyme TransportVehicle (ETV) programs, such as DNL952 (ETV:GAA) for Pompe disease.
• Antibody TransportVehicle (ATV) programs, such as DNL921 (ATV:Abeta) for Alzheimer's disease.
• Oligonucleotide TransportVehicle (OTV) programs, such as DNL628 (OTV:MAPT) for Alzheimer's disease.

The company expects to continue expanding this TV-enabled pipeline, bringing forward one to two new programs annually.

Preclinical data suggesting reduced ARIA risk for ATV:Abeta in Alzheimer's disease.

The ATV-enabled investigational therapy, DNL921 (ATV:Abeta), is designed to reduce amyloid plaques while avoiding the risk of amyloid-related imaging abnormalities (ARIA), a major safety concern with first-generation anti-amyloid drugs. Preclinical data for ATV:Abeta, published in the August 7, 2025, issue of Science, demonstrated that this approach improved brain distribution and reduced the risk of ARIA-like lesions and vascular inflammation in a mouse model compared to conventional antibody treatment. This was achieved by the TV platform-enabled brain delivery bypassing amyloid-laden large vessels by traveling through smaller capillaries.

The company's overall financial performance for the third quarter ended September 30, 2025, included a net loss of $126.9 million, resulting in a basic loss per share from continuing operations of $0.74.

Program Candidate	Therapeutic Class (TV Type)	Indication	Development Stage (Late 2025)
Tividenofusp alfa (DNL310)	Enzyme (ETV:IDS)	MPS II (Hunter syndrome)	Phase 2/3; BLA with revised PDUFA date of April 5, 2026
DNL921 (ATV:Abeta)	Antibody (ATV)	Alzheimer's disease	IND/CTA-enabling
DNL628 (OTV:MAPT)	Oligonucleotide (OTV)	Alzheimer's disease	Phase 1b
DNL126 (ETV:SGSH)	Enzyme (ETV)	MPS IIIA (Sanfilippo syndrome type A)	Phase 1/2; FDA alignment for accelerated approval path

Denali Therapeutics Inc. (DNLI) - Canvas Business Model: Customer Relationships

The relationships Denali Therapeutics Inc. maintains with key external stakeholders-partners, regulators, and patient communities-are central to advancing its TransportVehicle (TV) platform and commercial readiness as of late 2025.

Close, collaborative relationships with major pharmaceutical co-development partners.

Denali Therapeutics Inc. solidifies its development and commercialization strategy through significant financial and strategic alliances. The relationship with Royalty Pharma, for instance, is structured around a $275 million synthetic royalty funding agreement tied to the future net sales of tividenofusp alfa.

This collaboration involves specific financial tranches and royalty percentages:

Partner	Asset	Transaction Value	Upfront Payment	Contingent Payment	Royalty Rate
Royalty Pharma	Tividenofusp alfa (MPS II)	$275 million	$200 million (upon FDA accelerated approval)	$75 million (upon EMA approval by Dec 31, 2029)	9.25% on worldwide net sales

Beyond financing, Denali Therapeutics Inc. maintains strategic collaborations to expand its pipeline reach. The company has entered into strategic collaborations with Biogen targeting Alzheimer's disease and with Sanofi for lysosomal programs. These partnerships help Denali fund and advance its TV-enabled portfolio across rare and common diseases.

High-touch engagement with regulatory bodies like the FDA for priority review.

Engagement with the U.S. Food and Drug Administration (FDA) is intensive, particularly for its lead asset, tividenofusp alfa. The relationship has secured several designations, which streamline development and signal regulatory interest in the novel delivery platform.

Key regulatory milestones and interactions as of late 2025 include:

• Tividenofusp alfa received Breakthrough Therapy Designation on January 7, 2025.
• The Biologics License Application (BLA) for tividenofusp alfa was accepted for Priority Review.
• The Prescription Drug User Fee Act (PDUFA) target action date for tividenofusp alfa was extended to April 5, 2026.
• DNL126 for Sanfilippo syndrome Type A (MPS IIIA) was selected for the FDA's START program.
• The FDA placed a clinical hold on DNL952 for Pompe disease, requesting protocol amendments, including a lower starting dose.

The PDUFA date extension was due to a 'Major Amendment' submission concerning updated clinical pharmacology data, not efficacy or safety concerns. Denali Therapeutics Inc. is preparing for a U.S. launch, reflected in General and administrative expenses rising to $35.5 million for the third quarter ended September 30, 2025.

Developing patient support services for rare disease communities.

Denali Therapeutics Inc. emphasizes active engagement with the patient community to integrate real-life experiences into drug discovery and development. This commitment is crucial for rare diseases where patient populations are small and specific needs are high. For example, tividenofusp alfa targets Hunter syndrome (MPS II), which has approximately 1,500+ patients worldwide (excluding China and India). The DNL126 program targets MPS IIIA, also affecting about 1,500+ patients worldwide (excluding China and India).

The company's customer relationship strategy with these communities involves:

• Drawing patient insights from discovery through development stages.
• Fostering collaborations with patient advocacy organizations.
• Participating in and hosting community events for awareness building.

The focus on preparing for the launch of tividenofusp alfa suggests an investment in the necessary infrastructure to support patients post-approval.

Denali Therapeutics Inc. (DNLI) - Canvas Business Model: Channels

You're preparing to evaluate how Denali Therapeutics Inc. gets its value proposition to the market, which is heavily weighted on near-term product launches and platform validation. Here's the breakdown of their current channels as of late 2025.

Direct commercial sales force for the anticipated U.S. launch of tividenofusp alfa.

Denali Therapeutics Inc. is actively building out its internal capabilities to support the commercialization of tividenofusp alfa for Hunter syndrome (MPS II). The company is preparing for a U.S. launch anticipated in late 2025 or early 2026, with analyst consensus pointing toward an early 2026 launch. This preparation includes building a right-sized team in commercial and medical affairs to support this and future Enzyme TransportVehicle (ETV) launches. The U.S. Food and Drug Administration (FDA) has set the Prescription Drug User Fee Act (PDUFA) target action date for the BLA at April 5, 2026. Enrollment in the confirmatory Phase 2/3 COMPASS study's neuronopathic cohort (Cohort A) is expected to wrap up in December 2025.

Co-development and licensing agreements with global pharmaceutical companies.

Denali Therapeutics Inc. uses strategic partnerships to share development costs and leverage global reach, especially for its TransportVehicle (TV) platform programs. The financial structure around the lead asset, tividenofusp alfa, involves a significant external funding mechanism.

Here's a look at the key external financial and collaboration channel details:

Partner/Agreement Type	Program/Asset	Financial/Structural Detail
Royalty Pharma (Synthetic Royalty Funding)	Tividenofusp alfa (DNL310)	$275 million total agreement based on future net sales.
Royalty Pharma (Upfront Payment)	Tividenofusp alfa (DNL310)	Initial payment of $200 million upon FDA accelerated approval.
Royalty Pharma (Contingent Payment)	Tividenofusp alfa (DNL310)	Additional $75 million upon European Medicines Agency (EMA) approval by December 31, 2029.
Royalty Pharma (Royalty Rate)	Tividenofusp alfa (DNL310)	9.25% royalty on worldwide net sales, ceasing upon 3.0x return or 2.5x return by Q1 2039.
Biogen (Co-development)	BIIB122/DNL151 (Parkinson's)	50/50 U.S. commercial rights. Phase 2b LUMA study fully enrolled in May 2025.
Takeda (Co-development)	TAK-593/DNL593 (FTD-GRN)	Collaboration ongoing; Phase 1/2 study is active.
Sanofi (Licensing)	SAR443122/DNL758 (Ulcerative Colitis)	Denali Therapeutics Inc. stands to receive royalty payments.

These deals help fund the preparation for launch, as Denali Therapeutics Inc. reported cash, cash equivalents, and marketable securities of approximately $872.9 million as of September 30, 2025.

Regulatory submissions (BLA/IND) to the FDA and EMA for market access.

Market access is channeled directly through regulatory filings, which have seen significant progress in 2025. The BLA for tividenofusp alfa was accepted by the FDA in July 2025 for priority review. The initial PDUFA date was January 5, 2026, but an extension to April 5, 2026, followed the submission of additional clinical pharmacology data classified as a Major Amendment. The BLA rolling submission was initiated in April 2025.

For DNL126 in Sanfilippo syndrome Type A (MPS IIIA), Denali Therapeutics Inc. has alignment with the FDA on an accelerated approval path. The Phase 1/2 study is nearing completion of enrollment, with a potential commercial launch targeted by the end of 2027 and BLA submission anticipated in 2027. Furthermore, the company plans to submit regulatory applications in 2025 to start clinical testing for one to two additional TV-enabled programs. For DNL952 in Pompe disease, a response was submitted to the FDA following a clinical hold, and the company anticipates submitting a Clinical Trial Application (CTA) in Europe in the first half of 2026.

Scientific publications and presentations to validate platform technology.

Validation of the proprietary TransportVehicle (TV) platform is a key channel for building scientific credibility and attracting future partners. Denali Therapeutics Inc. has actively published data supporting its technology in 2025.

• Preclinical data on the Antibody TransportVehicle (ATV):Abeta program for Alzheimer's disease was published in the journal Science on August 7, 2025.
• The company presented primary analysis of the Phase 1/2 study for DNL126 at the 2025 WORLDSymposium conference, held February 3-7, 2025.
• The CEO presented key 2025 milestones at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025.
• A publication detailing the use of the TV platform to transport antisense oligonucleotides across the blood-brain barrier appeared in Science Translational Medicines on August 14, 2024.

The company also opened its in-house clinical biomanufacturing facility in Salt Lake City, Utah, in March 2025, which expands U.S. manufacturing capabilities. Finance: draft 13-week cash view by Friday.

Denali Therapeutics Inc. (DNLI) - Canvas Business Model: Customer Segments

You're looking at the core groups Denali Therapeutics Inc. (DNLI) is targeting with its TransportVehicle (TV) platform, which is designed to get large molecules across the blood-brain barrier (BBB). This focus splits clearly across rare diseases where they have near-term commercial plans, and common neurodegenerative diseases where the potential scale is massive.

Patients with rare lysosomal storage diseases (Hunter syndrome, Sanfilippo syndrome)

This segment represents the most immediate commercial opportunity, centered on enzyme replacement therapies that can now reach the brain thanks to the TV platform. For Hunter syndrome, caused by iduronate-2-sulfatase (IDS) deficiency, the lead candidate is tividenofusp alfa. Denali Therapeutics is actively preparing for a commercial launch in late 2025 or early 2026, following the FDA BLA review with a target action date around early 2026. The worldwide patient population for Hunter syndrome (MPS II), excluding China and India, is estimated to be about 2000 individuals.

For Sanfilippo syndrome Type A (MPS IIIA), the program DNL126 is advancing, with enrollment completed for the Phase 1/2 study as of the third quarter of 2025, supporting an accelerated approval path.

Here's a quick look at the rare disease focus:

• Tividenofusp alfa (MPS II): Preparing for launch late 2025 or early 2026.
• DNL126 (MPS IIIA): Enrollment for Phase 1/2 study completed in Q3 2025.
• These orphan disease products aim for high margins from small patient numbers.

Patients with common neurodegenerative diseases (Parkinson's, Alzheimer's, FTD-GRN)

This is the long-term, high-volume target for Denali Therapeutics, leveraging the same BBB-crossing technology across multiple franchises. For Alzheimer's disease (AD), they are advancing DNL921 (ATV:Abeta) and DNL628 (OTV:MAPT). For Parkinson's disease (PD), they have an LRRK2 inhibitor program and DNL422 (OTV:SNCA). The potential market value for these common indications is substantial; analyst estimates suggest over $5B per indication for AD/PD.

The company also targets GRN-related frontotemporal dementia (FTD) with DNL593 (PTV:PGRN), which is categorized under their enzyme franchise due to the similar protein replacement approach.

The scale of the opportunity here is vast, with one segment estimate pointing to over 40M Patients WW across these broader disease areas.

Disease Area	Lead Program Example	Technology Franchise
Alzheimer's Disease	DNL921 (ATV:Abeta)	Antibody Transport Vehicle (ATV)
Parkinson's Disease	LRRK2 Inhibitor (BIIB122 with Biogen)	Small Molecule / TV-enabled
FTD-GRN	DNL593 (PTV:PGRN)	Enzyme Transport Vehicle (ETV)

Large pharmaceutical companies seeking innovative BBB-crossing technology

Denali Therapeutics Inc. actively partners to share development costs and commercial risk, which is evident in their financing and collaboration deals. These partners value the proprietary TransportVehicle platform as a key enabler for brain-penetrant medicines.

A major recent example involves the deal with Royalty Pharma, which provided Denali with up to $275 million in synthetic royalty funding based on tividenofusp alfa sales. This deal includes an initial payment of $200 million contingent on FDA accelerated approval. In exchange, Royalty Pharma receives a 9.25% royalty on worldwide net sales.

Beyond financing, strategic collaborations target specific disease areas:

• Biogen: Jointly developing LRRK2 small molecule inhibitors for Parkinson's disease.
• Sanofi: Collaboration focused on lysosomal programs.

The company is building out its internal infrastructure, like the large molecule manufacturing facility in Salt Lake City, Utah, to support the launch of these partnered and wholly-owned assets, which signals readiness for commercial scale.

Finance: review the cash runway based on Q3 2025 operating expenses of approximately $137.5 million quarterly.

Denali Therapeutics Inc. (DNLI) - Canvas Business Model: Cost Structure

You're looking at the hard numbers behind Denali Therapeutics Inc.'s operating expenses as they transition toward potential commercialization. The cost structure is heavily weighted toward discovery and development, which is typical for a late-stage biotech, but the recent figures show a clear shift in spending priorities.

High research and development (R&D) expenses remain the largest component of the cost base. For the third quarter ended September 30, 2025, total R&D expenses reached $102.0 million. This compares to $98.2 million for the same period in 2024. The net loss for Q3 2025 was $126.9 million.

The increase in R&D spending year-over-year was driven by specific operational expansions:

• Increase of $7.8 million in other research and development expenses.
• Increase of $6.4 million in personnel-related expenses.

Both of these increases are directly attributable to the commencement of operations at Denali Therapeutics' large molecule manufacturing facility in Salt Lake City, Utah.

Increased general and administrative (G&A) costs reflect the company's readiness for a potential product launch. G&A expenses for Q3 2025 were $35.5 million, up from $24.9 million in Q3 2024. This $10.6 million increase was primarily due to preparatory activities for a potential commercial launch for tividenofusp alfa.

The investment in internal infrastructure, specifically the Salt Lake City facility, is a major cost driver, tying together R&D and manufacturing overhead. Denali Therapeutics celebrated the grand opening of this cutting-edge biomanufacturing facility in March 2025.

Here's a quick look at how the operating expenses trended in the recent quarters leading up to Q3 2025:

Period Ended	R&D Expenses (Millions USD)	G&A Expenses (Millions USD)	SLC Facility Impact Mentioned
March 31, 2025 (Q1)	$116.2 million	Increase driven in part by commencement of operations	Yes
June 30, 2025 (Q2)	$102.7 million	$32.3 million	Yes
September 30, 2025 (Q3)	$102.0 million	$35.5 million	Yes

Clinical trial execution and regulatory submission costs are embedded within the R&D and G&A figures, but specific milestones point to recent expenditures. The costs associated with the tividenofusp alfa Biologics License Application (BLA) submission, completed in May 2025, contributed to the G&A increase in Q1 2025. Furthermore, Denali Therapeutics submitted Clinical Trial Applications/Investigational New Drug applications (CTAs/INDs) in October 2025 to initiate trials for DNL628 (OTV:MAPT) and DNL952 (ETV:GAA).

The cost structure also reflects a strategic shift away from older programs. For Q3 2025, R&D expenses saw a decrease of $10.2 million in external expenses for small molecule programs, which partially offset the increases related to the Salt Lake City facility. This suggests a focused deployment of capital toward the TransportVehicle (TV) platform programs nearing the finish line.

Finance: draft 13-week cash view by Friday.

Denali Therapeutics Inc. (DNLI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Denali Therapeutics Inc. (DNLI) as of late 2025, and honestly, the story right now is about future potential being funded by strategic, non-sales-based deals, given the current recognized revenue picture.

For the quarter ended September 30, 2025, Denali Therapeutics reported revenue of exactly $0.00. That number tells you the company is still pre-commercial for its key pipeline assets, so the current cash flow is driven by partnerships and financing events, not product sales.

Collaboration revenue from strategic partners like Biogen or Takeda is a key component, though specific recognized amounts for Q3 2025 aren't detailed as product sales yet. Still, the G&A expenses increased to $35.5 million for the quarter, driven by preparatory activities for a potential commercial launch for tividenofusp alfa, which signals readiness for that revenue stream to activate.

Anticipated net product sales of tividenofusp alfa (DNL310) post-approval represent the major future revenue driver. While specific sales forecasts for 2026 or beyond aren't on this canvas block, the company is actively preparing its commercial team for launch following the BLA review process.

Upfront and milestone payments from new and existing licensing deals are crucial for funding operations before product revenue hits. We see evidence of this funding structure in the recent Royalty Pharma agreement, which is a major near-term cash event.

Royalty income from licensed programs like SAR443122 (Sanofi) is another expected stream, though the specific income recognized in the third quarter of 2025 isn't explicitly broken out in the top-line revenue of $0.00.

The most concrete financial number right now comes from the synthetic royalty funding agreement announced in December 2025. Here's the quick math on that deal with Royalty Pharma:

Funding Component	Amount	Contingency/Trigger
Initial Payment from Royalty Pharma	$200 million	Closing, subject to U.S. FDA accelerated approval of tividenofusp alfa
Additional Payment from Royalty Pharma	$75 million	European Medicines Agency (EMA) approval by December 31, 2029
Total Potential Funding	$275 million	Combined initial and EMA milestone

This deal directly impacts the near-term financial runway, as cash, cash equivalents, and marketable securities stood at approximately $872.9 million as of September 30, 2025, before this funding closes. The structure of this funding ties future revenue directly to this financing event:

• Royalty Pharma receives a 9.25% royalty on worldwide net sales of tividenofusp alfa.
• Royalty payments cease upon reaching a multiple of 3.0x.
• The multiple reduces to 2.5x if achieved by the first quarter of 2039.

So, you have a current revenue of zero, but a guaranteed $200 million coming in contingent on FDA action, which is what's funding the next phase of development and launch prep. Finance: draft 13-week cash view by Friday.